ANAGASTRA 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Anagastra 40 mg Powder for Solution for Injection

pantoprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Anagastra and what is it used for
2. What you need to know before you use Anagastra
3. How to use Anagastra
4. Possible side effects

5 Storage of Anagastra

1. Contents of the pack and further information

1. What is Anagastra and what is it used for

Anagastra contains the active substance pantoprazole

Anagastra is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid. This medicine is injected into a vein and will only be given to you if your doctor considers that injection of pantoprazole, at this time, is more convenient for you than pantoprazole tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.

Anagastra is used for the treatment in adults of:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by acid reflux from the stomach.

• Stomach and duodenal ulcers

• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you use Anagastra

Do not use Anagastra

• If you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to medicines that contain other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Anagastra:

• If you have severe liver problems. Inform your doctor if you have ever had liver problems in the past. He will perform more frequent monitoring of liver enzymes. In case of an increase in liver enzymes, treatment should be discontinued.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told that you are at risk of osteoporosis (e.g., if you are taking corticosteroids).
• If you are taking Anagastra for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, go to your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Anagastra to reduce stomach acidity.
• If you get a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Anagastra. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediatelybefore or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as Anagastra has been associated with a small increase in infectious diarrhea.
• serious skin reactions have been reported in relation to treatment with Anagastra, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and erythema multiforme. Stop taking Anagastra and call your doctor immediately if you experience any of the symptoms related to serious skin reactions described in section 4.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole may alleviate cancer symptoms and could delay its diagnosis. If, despite treatment, your symptoms persist, further tests will be performed.

Children and adolescents

The use of Anagastra is not recommended in children as it has not been tested in children under 18 years of age.

Using Anagastra with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Anagastra may affect the efficacy of other medicines; inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) as Anagastra may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily discontinue treatment with Anagastra because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) if you are taking fluvoxamine; your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Talk to your doctor before taking Anagastra if you need to have a specific urine test (for THC, tetrahydrocannabinol).

Pregnancy, breastfeeding, and fertility

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Anagastra has no significant influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Anagastra contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use Anagastra

Your nurse or doctor will administer the daily dose as an injection into a vein over a period of 2-15 minutes.

The recommended dose is:

Adults

For the treatment of gastric ulcers, duodenal ulcers, and reflux esophagitis.

One vial (40 mg of pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion.

Two vials (80 mg of pantoprazole) per day.

Subsequently, your doctor may adjust the dose depending on the amount of acid secretion you produce. If you are prescribed more than two vials (80 mg) per day, the injections will be administered in equal doses. Your doctor may prescribe a dose of more than four vials (160 mg) per day for a short period. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce the amount of stomach acid.

Patients with liver problems

• If you have severe liver problems, the daily injection should be only 20 mg (half a vial).

Use in children and adolescents

• The use of these injections is not recommended in children and adolescents under 18 years of age.

If you use more Anagastra than you should

This medicine is controlled with caution by your nurse or doctor, so it is very unlikely that you will receive more than you should.

There are no known symptoms of overdose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor or pharmacist.

• Severe allergic reactions (raremay affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, swelling of the face of allergic origin (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin reactions (frequency not known;frequency cannot be estimated from the available data):you may notice one or more of the following - blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals, or sensitivity/skin rash, particularly in areas of skin exposed to light/sun. You may also have joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes. (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), photosensitivity). Circular or target-like reddish spots on the trunk, often with blisters in the center, peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). Generalized rash, elevated body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known):yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size sometimes with pain when urinating or pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

• Common(may affect up to 1 in 10 patients)

Inflammation of the vein wall and blood clots (thrombophlebitis) at the injection site, benign stomach polyps.

• Uncommon(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

• Rare(may affect up to 1 in 1,000 patients)

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; elevated body temperature; high fever; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(may affect up to 1 in 10,000 patients)

Disorientation

• Frequency not known(cannot be estimated from the available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pinching, numbness, burning sensation, or tingling, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 patients)

Increased liver enzymes.

• Rare(may affect up to 1 in 1,000 patients)

Increased bilirubin; increased fat in the blood; sharp drop in white blood cell count, associated with high fever.

• Very rare(may affect up to 1 in 10,000 patients)

Decreased platelet count, which may cause bleeding or more bruising than usual; decreased white blood cell count, which may lead to more frequent infections; abnormal decrease in the balance between red and white blood cell and platelet counts.

• Frequency not known (cannot be estimated from the available data)

Decrease in sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anagastra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C

Store the vial in the outer carton to protect it from light.

Use the reconstituted solution within 12 hours

Use the reconstituted and diluted solution within 12 hours

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user and normally should not exceed 12 hours at a temperature above 25°C.

Do not use Anagastra 40 mg i.v. if you notice that the appearance has changed (e.g., if you notice turbidity or precipitation)

Medicines should not be disposed of via wastewater or household waste. Place the empty vials and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the empty vials and unused medicines. This will help protect the environment.

6. Container Contents and Additional Information

Composition ofAnagastra

The active ingredient is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium).

The other components are: disodium edetate and sodium hydroxide (to adjust the pH).

Appearance of the Product and Container Contents ofAnagastra

Anagastra is a white or off-white powder for solution for injection. It is presented in a 10 ml glass vial (type I) with an aluminum cap and a gray rubber stopper containing 40 mg of powder for solution for injection.

Anagastra is available in the following package sizes:

Package with 1 vial

Package with 5 (5 packages of 1) vials

Clinical package with 1 vial

Clinical package with 5 (5 packages of 1) vials

Clinical package with 10 (10 packages of 1) vials

Clinical package with 20 (20 packages of 1) vials

Only some package sizes may be marketed.

Marketing Authorization Holder

Takeda GmbH

Byk Gulden Strasse, 2 (Konstanz)-78467

Germany

Manufacturer

Takeda GmbH

Production site Singen

Robert Bosch Strasse, 8

78224 Singen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Takeda Farmacéutica España, S.A.

Calle Albacete, 5, 9th floor,

Edificio Los Cubos

28027 Madrid

Spain

Phone: +34 91 790 42 22

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:04/2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for doctors or healthcare professionals:

The solution for immediate use is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution into the vial containing the powder. This solution can be administered directly or diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution or 5% glucose solution for injection or 55 mg/ml (5%) glucose solution for injection. For dilution, glass or plastic containers should be used.

Anagastra should not be prepared or mixed with solvents other than those specified.

After reconstitution, the solution can be used within 12 hours, although from a microbiological point of view, the product should be used immediately. If not, the storage within the time and conditions of use is the responsibility of the user and should not normally exceed 12 hours and 25°C.

The medication will be administered intravenously over 2-15 minutes.

Any remaining product in the vial or any vial with a change in its visual appearance (e.g., if turbidity or precipitation is observed) should be discarded.